Proposed improvements as depicted in this paper are an effort to make better my own blood pump patented under U.S. Pat. No. 4,012,177, main thrust for improvements here is to get a simpler structure and improve hemolysis, while not changing superior features of ref. #6 pump, namely: partial tube's squeeze by means of employing two check valves to replace rollers valving action, requiring total continuous squeeze over a long and wide path of the tube in order to maintain the delivery of blood at pressures required, namely 720 mmHg or 12.7 PSI. Major problem in conventional blood pumps is that they use the rollers not only to move the fluid, but also to maintain the pressure in discharge part of tubing, to do so all their rollers have to squeeze flat the tubing along the whole length of contact. Large area of blood film is trapped along inside whole surface of tube contact under mechanically adjusted (from outside) pressure by rollers. Blood cells like eritrocites in said film are destroyed and debris of this destruction-free hemoglobine is washed away by each new roll into the blood stream, while fresh blood covers inside tube area again, this causes hemolysis. We will discuss this later in more detail. Simplification of elements was also very important, hard to fabricate, as suggested in U.S. Pat. No. 4,012,177, Blood Pump Tube Element (in brief BPTE) now is conceived to be straight and in such a position relative to rollers to permit only one roller at a time to depress partially the tube wall of BPTE. Tube reshaping rollers were introduced, prior art in themselves, but in combination with partial tube squeeze, this presents first time that reshaping rollers will be successfully used, in view that in prior art tube reshaping from fully flat to circular introduces very high hoop stresses in tube. This stress problem in conventional pumps using tube reshaping rollers will be discussed now in connection with FIGS. 5 & 6. Reduction of stress in tube's wall means more reliable blood pump. Conventional blood pumps place "reshaping" rollers one at the top and one at the bottom of a tube at a distance approximately 1/8" from the tube, one pair in front, one pair behind the tube's compressing roller, and they mainly don't reshape, but they guide the tube. FIG. 5 illustrates a case when reshaping roller #41 is placed too close to compressing roller #40 and at a distance of 0-1/32" from tube, crosshatched areas of tube present locations on a tube where overstress (cracks) will occur. Roller #41A is shown on FIG. 5 to depict together with #41 the location of tube's guide rollers in prior art. FIG. #6 shows that if rollers #40 and #41 are spread more apart it will not help much. Ultimately, by reducing the diameter of rollers or increasing the size of pump, rollers #40 and #41 are so far apart, stress problem will be over, but tube by itself (far away from compressing roller) will recover to circular shape, thus reshaping rollers will become superfluous. Conventional pumps, in view of above limitations, have to depend on elasticity of their tube walls for amount of recovery time, i.e. suction time. More plastic walls--longer time, smaller delivery, so said pumps will not be able to increase the delivery by increasing its RPM after a point where said suction time lags increase in RPM. Proposed pulsating blood pump (in brief PBP) here, with improvements recited above, will increase the delivery with increase in RPM without above limitations. The delivery of PBP may also be effected by depressing tube wall #33 more or less by roller(s) #24. The choices to change delivery two ways allow the trade of, namely, PBP may be set to run at higher RPM and smaller tube displacement to optimize the durability of BPTE, this may look like an obvious choice, but none of the referenced pumps has this feature. Unlimited increase in its RPM of PBP combined with pulsating delivery opens up a new avenue, in some future day, where this type of pump may be used to speed up a cure of some of the human diseases. It is observed that normal reaction of human body to combat some infections: bacterial, viral, by increased pulse rate (temperature) apparently rushing antibodies, leukocytes and others at increased rate (pulse) to fight invaders. Above suggestion may be called highly speculative and in layman's language, but say if only for sake of test supply of blood to diseased area is increased to say 300 pulses per minute by use of outside pump (blood diverted and returned to normal patient stream after a while) would this have a healing effect or would some other rates than 300 ppm or other person's blood or fluid (vaccine) be curvature remains to be answered. No test(s) have been made in this area, but this author suggests that PBP as conceived may be at least used for this kind of research besides its main application for heart coronary bypass and transplant surgeries. Integral part of the improvements of PBP is the hub #28 conceived to be directly mounted on electric motor's output shaft (RPM of this motor may be changed electronically). Many of the conventional blood pumps have (mechanical gears or V-belt) reductors which decrease their reliability and add to cost. All of, or most of, blood pumps have a hand crank which (in case of catastrophic failure of electrical or mechanical parts) is used to run pump by hand. PBP's hub #28 has a .about. twice longer keyway hole in a center than needed for mounting said hub #28 on an electric motor, provided for a hand crank, this obvious safety feature is recited here for purposes of pointing out that conventional pumps with reductors are much harder to move by hand from reduction side because of resistance of the reductor. PBP has a clear advantage in this area. Another ultimate safety feature of PBP is BPTE #10 which alone, out of PBP, may pump the blood by outside operator depressing its tube walls by fingers of his hands. This may be obvious to many, but it is mentioned here to stress the adaptability and functionality of PBP in its simplest form. In this respect BPTE resembles some prior art syphon tubes. However none of prior art syphons would be able to work in the electro-mechanical pump such as PBP without improvements on syphons and pump, needed for blood pumping, as suggested here for PBP. Following future research breakthroughs BPTE #10 alone may be used to prolong (save) the life of heart failure (attack) victims before medics will be able to reach them. In this vision that neighbors and/or relatives may be able to connect the BPTE, say to left hand artery and vein near heart's ventricule/chamber and temporary by hand pump blood say for 10-20 minutes, until the help arrives. This highly speculative suggestion is written in layman's language and may be incorrect from today's medical standpoint, but if nothing else it may trigger a research in this area and at this time. Not to lose contact with reality, it is stressed again that at the present time, main application of PBP is for coronary bypass and heart transplant operations. Said hub has four rollers #24 conceived to compress, and four rollers #23 conceived to reshape tube #33, said rollers are mounted by their respective shafts #27 and #32 to said hub in a simple way, FIGS. 1, 2 and 3. Requirements for dimensional tolerances in this assembly are almost non-existing in comparison with conventional pump's very tight dim. tolerances required to maintain tube occlusion. All eight rollers are set screw attached to eight shafts and their axial position along said shafts (permanent during pump operation) may be changed, although it is conceived that need for this change will not occur often, since preferred change of pump delivery is by changing its RPM. Also limited movement of sliding plate #25, say 1/4", will not require said axial adjustment of rollers. The sliding plate is an integral part of PBP conceived to carry one or more BPTEs #10, FIGS. 1, 2 and 3. The plate is pivot (#26) mounted to allow sliding and bolted down by screw #31 to base #30 to prevent its movement while pump is running. Here also it is pointed out that sliding plate in itself as well as its assembly with BPTE's base plate #30 and hub #28 require no better tolerances on their fabrication dimensions than say 1/16" plus-minus. Result is the same: This PBP doesn't require occlusion adjustment. FIG. #4 is illustrating an arrangement where two BPTEs #10 are placed above each other. Rollers #23 are staggered in order to touch to reshape only upper or only lower BPTE, one at a time. FIG. #4 shows the structure of reduced to practice PBP, my prototype. FIG. #4 shows two rollers #24 are attached to longer shafts #35 while other two are attached to short shafts #32, also an extra plate #36 is placed on top of upper BPTE, equivalent to plate #20 in FIGS. 1 and 2. Simplicity, loose dim. tolerances and cost are improvements here over the conventional blood pumps.
The most important improvement in my PBP is the structure of BPTE #10. This structure shape of check valves and shape of their body placed inside tube #33 form with said tube two internal cavities to effect formation of relatively stagnant "dead" blood flow zone essential to reduction of flow friction and turbulence and so hemolysis of blood. FIG. #7 illustrates this effect where "dead" flow zone is approximately depicted by crosshatched areas. Main flow in a middle shown by arrows while some of remaining "back flow" and turbulance shown by arrows near the tube's wall. Picture similar to FIG. #7 was observed in tests. Test results (mainly amount of free hemoglobin as a measure of destruction of eritrocites, in blood, by pump action) will be disclosed later. Test is also a measure of friction and turbulence inside the BPTE. Without recited improvements above and construction as shown (FIGS. 1 and 2) of BPTE the PBP will be impossible. Continuous blood flow pumps, widely used at present time, deliver blood at near non-pulsating pressure because rollers assembly turns at constant speed. Some major blood pump manufacturers (indirectly admitting shortcomings of continuous flow pumps) have made so-called "pulsatile pressure" new line of blood pumps at the expense of adding complicated electro-mechanical brakes to their continuous flow blood pumps now in use and marketed. There is no doubt, "pulsatile flow" of blood is made at high cost, namely increase in hemolysis, and as in any complicated device, drop in reliability. Full pulsating blood flow, as achieved with simple device such as PBP, is a major improvement only if it is achieved with comparably low hemolysis of blood effect. Continuous blood pump delivery tends to poorly supply with oxygen periferal (distant from the heart) human body organs. This problem is very much pronounced in the cerebral region, namely starvation in oxygen is causing destruction of brain cells. As explained here, pulsating flow is very much desirable for good perfusion. The PBP is superior to continuous flow pumps, as mentioned earlier, by ability to generate relatively high pressure pulses, say 720 mm Hg or 12.7 PSI, this needed to penetrate the average oxigenator plus human body if oxigenator is placed at discharge port of PBP. When the oxigenator is placed next to suction port of some conventional pumps, this is a poor choice, since it will be undesirable to pressurize blood vessels in human body to say 720 mm Hg by placing patient in front of oxigenator. The prior art states the reason for this is that pump shall suck from instead of pushing through blood in oxigenator. Some of the large vessels like great aorta 3/4"-1" in diameter, 0.03"-0.02" thick wall, may see hoop stress 100-150 PSI, which may propagate cracks in walls of large blood vessels, especially in older patients. Imagine if oxigenator gets clogged up and pressure check-up system fails, some of large blood vessels now will burst for sure. Another possibility of clogged up oxigenator (when blood is sucked from it) that vacuum in pump is low (back flow) due to occlusions, so conventional pump becomes unoperable. Advantage here is that PBP shall have as conceived the oxigenator always first connected to discharge, so after loosing 500 mm Hg through oxigenator, next, blood vessels of patient will see only about 200 mm Hg and then blood will go to a return container (placed about 4 feet above suction port of BPTE for priming purposes of pump) and than back to said suction port thus completing the cycle. Raise in 200 mm Hg of about 80 mm Hg is due to said 4 foot elevation of return container which in itself is beneficial for keeping the air out of the system. Due to technical difficulties to connect directly to blood flow differential manometer and then pressure transducer to sense velocity pressure (theoretical method to determine the rate of flow in closed fluid circuits) conventional pump manufacturers would calibrate their digital flow meters by actually measuring the output of pump at number of RPMs at some pressure. Problem--pressure changes. The flow feed-back control will compare RPM of pump with the RPM of preset flow and feed back the difference to slow down or increase the RPM of electric motor of the pump. This method seems to be right if only median pressure resistance by which they calibrated the pump would be close to actual resistance to the flow, the pressure, as seen in part above, may be changing greatly, for example if oxigenator resistance to flow due to clogging goes say from 500 mm Hg to 1000 mm Hg actual rate of flow will fall more than twice because 1000 mm Hg may cause back flow (roller's mechanical pressure against the tube insufficient to keep it shut) but this change in flow will not show on digital meter, so since it will not be noticed, it will not be corrected. Check valves of PBP will have practically no leaks to cause fluid back flow and than when calibrated properly, change in flow alone will not change RPM of pump, instead flow or pressure changes or both will trigger feed back electrical signal to maintain preset flow rate and pressure as displayed on digital meter. It shall be mentioned also that a pressure transducer for PBP is located at tubing outlet from oxigenator and between oxigenator and patient to sense pressure drop through oxigenator and send electrical warning signal to control loops of pump. Control of flow circuits of PBP are precalibrated so that readout on digital flow meter will be proportional not only to RPM of pump but also to pressure signal of said pressure transducer. Blood flow regime now is in true visual and electro-mechanical control. Conventional pumps, even if they had made all above calibrations may have false blood flow rate readout, and its correction (due to the potential uncontrollable drops of pressure caused by backflow leaks inherent in these pumps caused by unpredictable occlusion) is undependable. Not to lose the sense for major improvement namely less hemolysis in view of above recited improvements, once more we have to dramatize the awesome agitation of blood cells during the average heart coronary bypass surgery, lasting say four hours. Tightly pressing the tube flat, rollers of conventional blood pumps engage said tube (say 1/2" ID on length of about 12") over 18.8 sq. in. about 192,000 times during four hours time (4 rollers/rev..times.200 RPM.times.240 min.). The word agitation may as well be called destruction of blood cells. Long heart transplant operations may reach one million tube engagements. Although there are a number of methods used to test the amount of blood cells destruction during the pumping process like: free hemoglobin count test, hematocrit and heptoglobine tests, etc., full account of real damage to human body, after one of these surgeries, may only be assessed by the length of time that each individual patient takes for a full recovery. It is also estimated that 10-15% more of patients may survive the ordeal of surgery if pumps used were less hemolytical. The PCT reference No. WO 82/04291 discloses a pump that illustrates that prior art.
To be more specific here, test results of my PBP and PCT reference #9 will be reduced here to comparable test conditions. Leading conventional pump, LCP in brief, test results will also be shown.
Test parameters and conditions for my PBP and LCP are: Bovine blood recirculated, return container placed at 31/2' above the pump discharge valve to simulate .about.80 mm Hg resistance to flow. LCP pumping against 40 mm Hg column of blood, no oxigenators connected in the flow circuits of either pump. The discharges were set for 4.0 lit/min at 180 RPM, testing time 3.0 hours. The data for PCT reference figure #9 indicates that 50 mm Hg and 180 RPM are representative for his test. See pages 3/5 and figure 6, second curve. It is pointed out that due to lower test pressure resistance, mechanical pressure on the pump's tubes (preventing back flow past roller) was set low also. This will be prorated by linear relation, conservatively, since pump delivery pressure resistance, without fluid back flow, is exponentially proportional to mechanical pressure applied to squeeze the tube. In the following simple calculation the method used for linear prorating will be shown. The test results of LCP and PBP for additional free hemoglobin will be converted to (grams/liter/one passage of blood through pump) to conform to the PCT results. Increase in free hemoglobin for LCP was measured 11.7 mg %, i.e. 11.7 mg/100 ml or 117 mg/lit; total flow: (4.0 lit/min.times.60.0 min.times.3.0 hr)=720 lit; total number of turns; (3.0 hr.times.180 RPM.times.60. Min)=32, 400 turns; for two rollers squeezing the tube per each turn, as in LCP and PBP, the number of comparative blood passages is 64, 800; now 117.times.720/64,800.times.1000=0.0013 (g/lit/passage) for LCP; PBP (at 80 mg Hg) exhibits 14.8 mg % free hemoglobin, i.e. 148 mg/lit; now 148.times.720/64,800.times.1000=0.0016 (g/lit/passage). Adjusting LCP 2.times. upwards because it was working against 2.times. smaller pressure and reducing PCT by 2/3 for having 3 rotor units per turn, PCT, which reported 0.008 (g/lit/passage) because 0.008/1.5=00533.
Summary of Test Results: Comparing the generated free hemoglobin LCP goes to 0.0026 (g/lit/passage) or 58.1% more hemoglobin than PBP. PCT ref exhibits 0.0053 (g/lit/passage) or 233.3% more free hemoglobin than PBP.
Summary to objections to references: Other prior art references show some similar pump elements but do not disclose compatibility for blood pumping but nevertheless if their concepts were to be used for BP, no gap in tube between internal walls means hemolysis; gap or partial gap means inability to maintain blood delivery pressure 12.7 PSI average, tube totally flatened by depressing roller will crack in short time if tube's reshaping rollers are close behind depressing roller. My ref. #6, although it has useful conceptual innovations like: partial squeeze of tube allowed by check valves, is difficult to fabricate; may be also more hemolytical due to mutiplicity of chambers and may have a limit in upper pump's RPM due to the time lag between recovery to round cross section (by elasticity of dual tube walls) and time that next depressing roller will engage the tube.
In view of many years that innovators and manufacturers had not addressed themselves to the problems of existing blood pumps (hemolysis, manufacturing dimensional tolerances to maintain in the occlusion and maintain needed delivery pressure and flow capacity) creation of PBP in a simple manner with full pulsating (not pulsatile) pressure blood flow to add the momentum to penetrate the capillaries, to mention few of the benefits is significant. My recited improvements were not obvious, otherwise somebody will in all these years have manufactured the blood pumps without above problems. Claims of improvements are ever so more valid since this author had built and successfully tested the blood pump with above suggested improvements.